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Medical Device

Direxion Torqueable Microcatheter, NGMC/SINGLE/021/J/1RO/105; Material Number: M001195260

Recall date: 2026-10-28 · Source: FDA_DEVICE
Brand / Firm
Boston Scientific Cork, Ltd.
Product
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/J/1RO/105; Material Number: M001195260
Reason for recall
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Units affected
358
Description
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/J/1RO/105; Material Number: M001195260
View official recall notice →